Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
NCT01386541 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2012-05-07
Summary
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.
Conditions
Interventions
- DRUG
-
BYK324677
capsules, administered orally
Sponsors & Collaborators
-
Nycomed
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2011-09-30
- Completion
- 2011-11-30
Countries
- Germany
Study Locations
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